RecruitingPhase 2NCT07304232

Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

134 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

AML (Acute Myeloid Leukemia)Allogeneic Hematopoietic Cell Transplantation (HCT)

Summary

This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation. Trial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation. Study Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called cidabenamide (an HDAC inhibitor — a type of medication that changes how cancer genes are expressed) can help prevent AML (acute myeloid leukemia) from coming back after a stem cell transplant. It is aimed at patients with intermediate- or high-risk AML who are in remission after their transplant. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with AML with intermediate- or high-risk genetic features (based on current WHO criteria) - You achieved complete remission after your allogeneic (donor) stem cell transplant - You are enrolling 60–100 days after the transplant - Your performance status and organ function (kidneys, liver, bone marrow) meet the minimum requirements **You may NOT be eligible if...** - You have not achieved complete remission after transplant - Your cancer is low-risk or is a different type of blood cancer - You have serious organ damage, active infections, or significant complications from the transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide

Patients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval.